Medication Guide. CIPRO (Sip-row) (ciprofloxacin hydrochloride) Tablets for oral use. for oral suspension. Tablets for oral use

Transcription

1 Medicatin Guide CIPRO (Sip-rw) (ciprflxacin hydrchlride) Tablets fr ral use CIPRO (Sip-rw) (ciprflxacin hydrchlride) fr ral suspensin CIPRO XR (Sip-rw) (ciprflxacin hydrchlride) Tablets fr ral use CIPRO IV (Sip-rw) (ciprflxacin) Injectin fr intravenus infusin Read this Medicatin Guide befre yu start taking CIPRO and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut CIPRO? CIPRO, a flurquinlne antibacterial medicine, can cause serius side effects. Sme f these serius side effects culd result in death. If yu get any f the fllwing serius side effects while yu take CIPRO, get medical help right away. Talk with yur healthcare prvider abut whether yu shuld cntinue t take CIPRO. 1. Tendn rupture r swelling f the tendn (tendinitis). Tendn prblems can happen in peple f all ages wh take CIPRO. Tendns are tugh crds f tissue that cnnect muscles t bnes. Symptms f tendn prblems may include: pain swelling tears and inflammatin f tendns including the back f the ankle (Achilles), shulder, hand, r ther tendn sites. The risk f getting tendn prblems while yu take CIPRO is higher if yu: are ver 60 years f age are taking sterids (crticsterids) 37

2 have had a kidney, heart r lung transplant Tendn prblems can happen in peple wh d nt have the abve risk factrs when they take CIPRO. Other reasns that can increase yur risk f tendn prblems can include: physical activity r exercise kidney failure tendn prblems in the past, such as in peple with rheumatid arthritis (RA) Call yur healthcare prvider right away at the first sign f tendn pain, swelling r inflammatin. Stp taking CIPRO until tendinitis r tendn rupture has been ruled ut by yur healthcare prvider. Avid exercise and using the affected area. The mst cmmn area f pain and swelling is the Achilles tendn at the back f yur ankle. This can als happen with ther tendns. Talk t yur healthcare prvider abut the risk f tendn rupture with cntinued use f CIPRO. Yu may need a different antibitic that is nt a flurquinlne t treat yur infectin. Tendn rupture can happen while yu are taking r after yu have finished taking CIPRO. Tendn ruptures have happened up t several mnths after peple have finished taking their flurquinlne. Get medical help right away if yu get any f the fllwing signs r symptms f a tendn rupture: hear r feel a snap r pp in a tendn area bruising right after an injury in a tendn area unable t mve the affected area r bear weight 2. Wrsening f myasthenia gravis (a prblem that causes muscle weakness). Flurquinlnes like CIPRO may cause wrsening f myasthenia gravis symptms, including muscle weakness and breathing prblems. Call yur healthcare prvider right away if yu have any wrsening muscle weakness r breathing prblems. See What are the pssible side effects f CIPRO? What is CIPRO? CIPRO is a flurquinlne antibacterial medicine used in adults age 18 years and lder t treat certain infectins caused by certain germs called bacteria. These bacterial infectins include: urinary tract infectin chrnic prstate infectin lwer respiratry tract infectin 38

3 sinus infectin skin infectin bne and jint infectin nscmial pneumnia intra-abdminal infectin, cmplicated infectius diarrhea typhid (enteric) fever cervical and urethral gnrrhea, uncmplicated peple with a lw white bld cell cunt and a fever inhalatinal anthrax plague Studies f CIPRO fr use in the treatment f plague and anthrax were dne in animals nly, because plague and anthrax culd nt be studied in peple. CIPRO is als used in children yunger than 18 years f age t treat cmplicated urinary tract and kidney infectins r wh may have breathed in anthrax germs, have plague r have been expsed t plague germs. Children yunger than 18 years f age have a higher chance f getting bne, jint, r tendn (musculskeletal) prblems such as pain r swelling while taking CIPRO. CIPRO shuld nt be used as the first chice f antibacterial medicine in children under 18 years f age. CIPRO XR is nly used in adults 18 years f age and lder t treat urinary tract infectins (cmplicated and uncmplicated), including kidney infectins (pyelnephritis). It is nt knwn if CIPRO XR is safe and effective in children under 18 years f age. Wh shuld nt take CIPRO? D nt take CIPRO if yu: Have ever had a severe allergic reactin t an antibacterial medicine knwn as a flurquinlne, r are allergic t ciprflxacin hydrchlride r any f the ingredients in CIPRO. See the end f this Medicatin Guide fr a cmplete list f ingredients in CIPRO. Als take a medicine called tizanidine (Zanaflex ). Ask yur healthcare prvider if yu are nt sure. What shuld I tell my healthcare prvider befre taking CIPRO? Befre yu take CIPRO, tell yur healthcare prvider if yu: have tendn prblems have a disease that causes muscle weakness (myasthenia gravis) 39

4 have liver prblems have central nervus system prblems (such as epilepsy) have nerve prblems have r anyne in yur family has an irregular heartbeat, especially a cnditin called QT prlngatin have r have had seizures have kidney prblems. Yu may need a lwer dse f CIPRO if yur kidneys d nt wrk well. have jint prblems including rheumatid arthritis (RA) have truble swallwing pills have any ther medical cnditins are pregnant r plan t becme pregnant. It is nt knwn if CIPRO will harm yur unbrn baby. are breastfeeding r plan t breastfeed. CIPRO passes int breast milk. Yu and yur healthcare prvider shuld decide whether yu will take CIPRO r breastfeed. Yu shuld nt d bth. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and ver-the-cunter medicines, vitamins, and herbal supplements. CIPRO and ther medicines can affect each ther causing side effects. Especially tell yur healthcare prvider if yu take: a sterid medicine an anti-psychtic medicine a tricyclic antidepressant a water pill (diuretic) thephylline (such as The-24, Elixphyllin, Thechrn, Uniphyl, Thelair ) a medicine t cntrl yur heart rate r rhythm (antiarrhythmics) an ral anti-diabetes medicine phenytin (Fsphenytin Sdium, Cerebyx, Dilantin-125, Dilantin, Extended Phenytin Sdium, Prmpt Phenytin Sdium, Phenytek ) cyclsprine (Gengraf, Neral, Sandimmune, Sangcya ). a bld thinner (such as warfarin, Cumadin, Jantven ) methtrexate (Trexall ) rpinirle (Requip ) clzapine (Clzaril, Fazacl ODT ) 40

5 a Nn-Steridal Anti-Inflammatry Drug (NSAID). Many cmmn medicines fr pain relief are NSAIDs. Taking an NSAID while yu take CIPRO r ther flurquinlnes may increase yur risk f central nervus system effects and seizures. sildenafil (Viagra, Revati ) dulxetine prducts that cntain caffeine prbenecid (Prbalan, Cl-prbenecid ) certain medicines may keep CIPRO Tablets, CIPRO Oral Suspensin frm wrking crrectly. Take CIPRO Tablets and Oral Suspensin either 2 hurs befre r 6 hurs after taking these medicines, vitamins, r supplements: an antacid, multivitamin, r ther medicine r supplements that has magnesium, calcium, aluminum, irn, r zinc sucralfate (Carafate ) didansine (Videx, Videx EC ) Ask yur healthcare prvider fr a list f these medicines if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I take CIPRO? Take CIPRO exactly as yur healthcare prvider tells yu t take it. Yur healthcare prvider will tell yu hw much CIPRO t take and when t take it. Take CIPRO Tablets in the mrning and evening at abut the same time each day. Swallw the tablet whle. D nt split, crush r chew the tablet. Tell yur healthcare prvider if yu cannt swallw the tablet whle. Take CIPRO Oral Suspensin in the mrning and evening at abut the same time each day. Shake the CIPRO Oral Suspensin bttle well each time befre use fr abut 15 secnds t make sure the suspensin is mixed well. Clse the bttle cmpletely after use. Take CIPRO XR ne time each day at abut the same time each day. Swallw the tablet whle. D nt split, crush r chew the tablet. Tell yur healthcare prvider if yu cannt swallw the tablet whle. CIPRO IV is given t yu by intravenus (IV) infusin int yur vein, slwly, ver 60 minutes, as prescribed by yur healthcare prvider. CIPRO can be taken with r withut fd. CIPRO shuld nt be taken with dairy prducts (like milk r ygurt) r calciumfrtified juices alne, but may be taken with a meal that cntains these prducts. 41

6 Drink plenty f fluids while taking CIPRO. D nt skip any dses f CIPRO, r stp taking it, even if yu begin t feel better, until yu finish yur prescribed treatment unless: yu have tendn prblems. See What is the mst imprtant infrmatin I shuld knw abut CIPRO? yu have a serius allergic reactin. See What are the pssible side effects f CIPRO? yur healthcare prvider tells yu t stp taking CIPRO Taking all f yur CIPRO dses will help make sure that all f the bacteria are killed. Taking all f yur CIPRO dses will help lwer the chance that the bacteria will becme resistant t CIPRO. If yu becme resistant t CIPRO, CIPRO and ther antibacterial medicines may nt wrk fr yu in the future. If yu take t much CIPRO, call yur healthcare prvider r get medical help right away. What shuld I avid while taking CIPRO? CIPRO can make yu feel dizzy and lightheaded. D nt drive, perate machinery, r d ther activities that require mental alertness r crdinatin until yu knw hw CIPRO affects yu. Avid sunlamps, tanning beds, and try t limit yur time in the sun. CIPRO can make yur skin sensitive t the sun (phtsensitivity) and the light frm sunlamps and tanning beds. Yu culd get a severe sunburn, blisters r swelling f yur skin. If yu get any f these symptms while yu take CIPRO, call yur healthcare prvider right away. Yu shuld use a sunscreen and wear a hat and clthes that cver yur skin if yu have t be in sunlight. What are the pssible side effects f CIPRO? CIPRO may cause serius side effects, including: See, What is the mst imprtant infrmatin I shuld knw abut CIPRO? Serius allergic reactins. Serius allergic reactins, including death, can happen in peple taking flurquinlnes, including CIPRO, even after nly 1 dse. Stp taking CIPRO and get emergency medical help right away if yu get any f the fllwing symptms f a severe allergic reactin: hives truble breathing r swallwing swelling f the lips, tngue, face thrat tightness, harseness rapid heartbeat faint 42

7 skin rash Skin rash may happen in peple taking CIPRO even after nly 1 dse. Stp taking CIPRO at the first sign f a skin rash and call yur healthcare prvider. Skin rash may be a sign f a mre serius reactin t CIPRO. Liver damage (hepattxicity). Hepattxicity can happen in peple wh take CIPRO. Call yur healthcare prvider right away if yu have unexplained symptms such as: nausea r vmiting unusual tiredness stmach pain lss f appetite fever light clred bwel weakness mvements abdminal pain r dark clred urine tenderness itching yellwing f yur skin r the whites f yur eyes Stp taking CIPRO and tell yur healthcare prvider right away if yu have yellwing f yur skin r white part f yur eyes, r if yu have dark urine. These can be signs f a serius reactin t CIPRO (a liver prblem). Central Nervus System (CNS) effects. Seizures have been reprted in peple wh take flurquinlne antibacterial medicines, including CIPRO. Tell yur healthcare prvider if yu have a histry f seizures. Ask yur healthcare prvider whether taking CIPRO will change yur risk f having a seizure. CNS side effects may happen as sn as after taking the first dse f CIPRO. Talk t yur healthcare prvider right away if yu get any f these side effects, r ther changes in md r behavir: seizures truble sleeping hear vices, see things, r nightmares sense things that are nt there (hallucinatins) feel lightheaded r dizzy feel restless feel mre suspicius (parania) tremrs suicidal thughts r acts feel anxius r nervus headaches that will nt g away, with r withut blurred visin cnfusin depressin Intestine infectin (Pseudmembranus clitis). Pseudmembranus clitis can happen with many antibacterial medicines, including CIPRO. Call yur healthcare prvider right away if yu get watery diarrhea, diarrhea that des nt g away, r bldy stls. Yu may have stmach cramps and a fever. Pseudmembranus clitis can happen 2 r mre mnths after yu have finished yur antibacterial medicine. 43

8 Changes in sensatin and pssible nerve damage (Peripheral Neurpathy). Damage t the nerves in arms, hands, legs, r feet can happen in peple wh take flurquinlnes, including CIPRO. Talk with yur healthcare prvider right away if yu get any f the fllwing symptms f peripheral neurpathy in yur arms, hands, legs, r feet: pain burning tingling numbness weakness CIPRO may need t be stpped t prevent permanent nerve damage. Serius heart rhythm changes (QT prlngatin and trsade de pintes). Tell yur healthcare prvider right away if yu have a change in yur heart beat (a fast r irregular heartbeat), r if yu faint. CIPRO may cause a rare heart prblem knwn as prlngatin f the QT interval. This cnditin can cause an abnrmal heartbeat and can be very dangerus. The chances f this event are higher in peple: wh are elderly with a family histry f prlnged QT interval with lw bld ptassium (hypkalemia) wh take certain medicines t cntrl heart rhythm (antiarrhythmics) Jint Prblems. Increased chance f prblems with jints and tissues arund jints in children under 18 years ld can happen. Tell yur child s healthcare prvider if yur child has any jint prblems during r after treatment with CIPRO. Sensitivity t sunlight (phtsensitivity). See What shuld I avid while taking CIPRO? The mst cmmn side effects f CIPRO include: nausea diarrhea changes in liver functin tests vmiting rash Tell yur healthcare prvider abut any side effect that bthers yu, r that des nt g away. These are nt all the pssible side effects f CIPRO. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre CIPRO? CIPRO Tablets Stre at 20 t 25 C (68 t 77 F); excursins permitted t 15 t 30 C (59 t 86 F). CIPRO Oral Suspensin 44

9 Stre micrcapsules and diluent belw 25 C (77 F); excursins are permitted frm 15 C t 30 C (59 F t 86 F). D nt freeze. After yur CIPRO treatment is finished, safely thrw away any unused ral suspensin. CIPRO XR Stre CIPRO XR between 59 F t 86 F (15 C t 30 C). Keep CIPRO and all medicines ut f the reach f children. General Infrmatin abut the safe and effective use f CIPRO. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use CIPRO fr a cnditin fr which it is nt prescribed. D nt give CIPRO t ther peple, even if they have the same symptms that yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut CIPRO. If yu wuld like mre infrmatin abut CIPRO, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut CIPRO that is written fr healthcare prfessinals. Fr mre infrmatin call What are the ingredients in CIPRO? CIPRO Tablets: Active ingredient: ciprflxacin hydrchlride Inactive ingredients: crnstarch, micrcrystalline cellulse, silicn dixide, crspvidne, magnesium stearate, hyprmellse, titanium dixide, and plyethylene glycl CIPRO Oral Suspensin: Active ingredient: ciprflxacin hydrchlride Inactive ingredients: Micrcapsules cntains: pvidne, methacrylic acid cplymer, hyprmellse, magnesium stearate, and Plysrbate 20 Diluent cntains: medium-chain triglycerides, sucrse, sy-lecithin, water, and strawberry flavr CIPRO XR: Active ingredient: ciprflxacin hydrchlride Inactive ingredients: crspvidne, hyprmellse, magnesium stearate, plyethylene glycl, silica cllidal anhydrus, succinic acid, and titanium dixide CIPRO IV: Active ingredient: ciprflxacin Inactive ingredients: lactic acid as a slubilizing agent, hydrchlric acid fr ph adjustment This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. 45

10 Manufactured fr: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ Manufactured in Germany CIPRO is a registered trademark f Bayer Aktiengesellschaft. Rx Only 2015 Bayer HealthCare Pharmaceuticals Inc. CIPRO (ciprflxacin*) 5% and 10% Oral Suspensin Manufactured in Italy CIPRO (ciprflxacin HCl) Tablets Manufactured in Germany Revised: March